A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04847557
Collaborator
(none)
700
Enrollment
133
Locations
2
Arms
31.1
Anticipated Duration (Months)
5.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Detailed Description

The study will continue until approximately 52 weeks after the last participant is randomized. The maximum duration of an individual's participation is estimated to be 120 weeks and will depend on duration of study enrollment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
700 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)
Actual Study Start Date :
Apr 20, 2021
Anticipated Primary Completion Date :
Nov 22, 2023
Anticipated Study Completion Date :
Nov 22, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Tirzepatide

Tirzepatide administered subcutaneously (SC)

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
  • Placebo Comparator: Placebo

    Placebo administered SC

    Other: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. A Hierarchical Composite of All-Cause Mortality, Heart Failure Events, 6-minute Walk Test Distance (6MWD) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) Category [Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks)]

      Hierarchical Composite of Time to All-Cause Mortality, Number of Heart Failure Events, Time to First HF Events, 6MWD, and KCCQ CSS will be assessed by the win ratio. The reported unit will be the total "wins" for each treatment group from performing a hierarchical comparison of the components.

    2. Change from Baseline in Exercise Capacity as Measured by 6MWD [Baseline, Week 52]

    Secondary Outcome Measures

    1. Percent Change from Baseline in Body Weight Loss [Baseline, Week 52]

    2. Change from Baseline in the KCCQ CSS [Baseline, Week 52]

    3. Change from Baseline in 6MWD [Baseline, Week 24]

    4. Percentage of Participants with New York Heart Association (NYHA) Class Change [Week 52]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Have a diagnosis of stable heart failure (NYHA class II-IV) and left ventricular ejection fraction (LVEF) ≥50%

    • Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide) > 200 pg/ml for participants without atrial fibrillation (AF), or >600 picogram/milliliter (pg/ml) for participants with AF, Structural heart disease (Left atrial enlargement) or Elevated left ventricular filling pressure

    • Estimated glomerular filtration rate (eGFR) <70 milliliter (ml)/minute (min)/1.73m² at screening, or HF decompensation within 12 months of screening,

    • Stable dose of heart failure medications within 4 weeks of screening

    • Body mass index (BMI) ≥30 kilograms per meter squared (kg/m²)

    • 6MWD 100-425m

    • KCCQ CSS ≤80

    Exclusion Criteria:
    • Have had a major cardiovascular event within the last 90 days of screening

    • Have had acute decompensated heart failure within 4 weeks of screening

    • Have non cardiac causes of functional impairment such as pulmonary arterial hypertension (PAH), severe chronic obstructive pulmonary disease (COPD), anemia, thyroid disease, musculoskeletal disease or orthopedic conditions

    • Presence of cardiac amyloidosis, cardiac accumulation disease, cardiomyopathy and severe valvular hear disease

    • HbA1c ≥9.5% or uncontrolled diabetes

    • History of proliferative diabetic retinopathy or diabetic maculopathy

    • Have a history of pancreatitis

    • eGFR <15 mL/min/1.73 m² or requiring dialysis at screening

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Heart Center ResearchHuntsvilleAlabamaUnited States35801
    2Westside Medical Associates of Los AngelesBeverly HillsCaliforniaUnited States90211
    3Valley Clinical Trials, Inc.CovinaCaliforniaUnited States91723
    4California Heart SpecialistsHuntington BeachCaliforniaUnited States92648
    5University of California San Diego - La JollaLa JollaCaliforniaUnited States92037
    6Amicis Research CenterNorthridgeCaliforniaUnited States91324
    7Valley Clinical Trials, Inc.NorthridgeCaliforniaUnited States91325
    8The Lundquist InstituteTorranceCaliforniaUnited States90502
    9South Denver Cardiology Associates, PCLittletonColoradoUnited States80120
    10Cardiology Associates of Fairfield County, P.C.StamfordConnecticutUnited States06905
    11Excel Medical Clinical TrialsBoca RatonFloridaUnited States33434
    12Clearwater Cardiovascular & Interventional ConsultantsClearwaterFloridaUnited States33756
    13Clearwater Cardiovascular & Interventional Consultants M.D., P.A.LargoFloridaUnited States33777
    14Infinite Clinical ResearchMiamiFloridaUnited States33133
    15Clearwater Cardiovascular & Interventional Consultants M.D., P.A.Safety HarborFloridaUnited States34695
    16Morehouse School Of MedicineAtlantaGeorgiaUnited States30310
    17St. Luke's Boise Medical CenterBoiseIdahoUnited States83712
    18Northwest Heart Clinical ResearchArlington HeightsIllinoisUnited States60005
    19UnityPoint Health MethodistPeoriaIllinoisUnited States61636
    20Midwest Heart & Vascular SpecialistsOverland ParkKansasUnited States66211
    21Grace Research - BossierBossier CityLouisianaUnited States71111
    22Grace Research - ShreveportShreveportLouisianaUnited States71105
    23Maryland Cardiovascular SpecialistsBaltimoreMarylandUnited States21229
    24McLaren Bay RegionBay CityMichiganUnited States48708
    25St. Louis Heart and Vascular, P.C.Saint LouisMissouriUnited States63136
    26Palm Research Center TenayaLas VegasNevadaUnited States89128
    27Cardiovascular Associates of the Delaware ValleyHaddon HeightsNew JerseyUnited States08035
    28Lovelace Medical CenterAlbuquerqueNew MexicoUnited States87102
    29Saratoga Cardiology AssociatesSaratoga SpringsNew YorkUnited States12866
    30Stony Brook UniversityStony BrookNew YorkUnited States11794
    31Aultman Hospital ResearchCantonOhioUnited States44710
    32Hightower Clinical Trial ServicesOklahoma CityOklahomaUnited States73102
    33Hillsboro CardiologyHillsboroOregonUnited States97123
    34Capital Area Research, LLCCamp HillPennsylvaniaUnited States17011
    35Doylestown HospitalDoylestownPennsylvaniaUnited States18901
    36UPMC Clinical TrialsPittsburghPennsylvaniaUnited States15213
    37Medical University of South CarolinaCharlestonSouth CarolinaUnited States29425
    38The Stern Cardiovascular FoundationGermantownTennesseeUnited States38138
    39DiscoveResearchBeaumontTexasUnited States77701
    40Sherman Clinical ResearchShermanTexasUnited States75092
    41Northwest Houston Heart CenterTomballTexasUnited States77375
    42Intermountain Medical CenterMurrayUtahUnited States84107
    43Pulse Heart InstitutePuyallupWashingtonUnited States98372
    44West Virginia UniversityMorgantownWest VirginiaUnited States26506
    45CIPREC-Centro de Investigacion y Prevencion Cardiovascular-CabaBuenos AiresArgentinaC1119ACN
    46Centro de Investigaciones Metabólicas (CINME)Ciudad Autónoma de Buenos AireBuenos AiresArgentinaC1027AAP
    47DIM Clínica PrivadaRamos MejíaBuenos AiresArgentina1704
    48Go Centro Medico San NicolásSan NicolasBuenos AiresArgentina2900
    49Fundación RespirarBuenos AiresBuenos AirArgentina1426
    50Mautalen Salud e InvestigaciónBuenos AiresCiudad Autónoma De Buenos AireArgentinaC1128AAF
    51Centro Medico Dr Laura Maffei Investigacion Clinica AplicadaCiudad Autonoma de Buenos AireCiudad Autónoma De Buenos AireArgentinaC1425AGC
    52Instituto Médico Río CuartoRío CuartoCórdobaArgentina5800
    53Instituto de Investigaciones Clínicas Rosario - Sanatorio DeltaRosarioSanta FeArgentina2000
    54Instituto Médico Especializado (IME)Buenos AiresArgentina1405
    55CEMEDICBuenos AiresArgentina1407
    56Instituto de Cardiología "Juana F. Cabral"CorrientesArgentina3400
    57Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)CórdobaArgentina5000
    58Hospital de Alta Complejidad "Pte. Juan Domingo Perón"FormosaArgentina3600
    59Centro Cardiovascular SaltaSaltaArgentina4406
    60Instituto Cardiovascular San LuisSan LuisArgentina5700
    61Centro de Investigaciones Clinicas del LitoralSanta FeArgentina3000
    62Universidade Federal de GoiasGoianiaGoiásBrazil74605-020
    63Hospital Angelina CaronCampina Grande do SulParanáBrazil83430-000
    64Centro de Pesquisa Clinica do CoracaoAcarajuSergipeBrazil49055-530
    65Loema Instituto de Pesquisa ClinicaCampinasSão PauloBrazil13010-001
    66Centro de Pesquisa Sao LucasCampinasSão PauloBrazil13034-685
    67Instituto de Pesquisa clinica de CampinasCampinasSão PauloBrazil13060-080
    68CAPED Centro Avancado Pesquisa e DiagnosticaRibeirao PretoSão PauloBrazil14026-900
    69Pesquisare SaudeSanto AndréSão PauloBrazil09080-110
    70Fundação Faculdade Regional de Medicina de São José do Rio PretoSão José do Rio PretoSão PauloBrazil15090000
    71IBPClin - Instituto Brasil de Pesquisa ClínicaRio de JaneiroBrazil22241-180
    72Peking University First HospitalBeijingBeijingChina100034
    73Beijing Friendship HospitalBeijingBeijingChina100050
    74Chinese PLA General HospitalBeijingBeijingChina100853
    75Fujian Provincial HospitalFuzhouFujianChina350001
    76Lanzhou university second hospitalLanzhouGansuChina730030
    77The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhouGuangdongChina
    78The First Hospital of Harbin Medical UniversityHarbinHeilongjiangChina150001
    79Wuhan University Medical College - Hubei Zhongshan HospitalWuhanHubeiChina430000
    80The Third Xiangya Hospital of Central South UniversityChangshaHunanChina410013
    81The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechnologyBaotouInner MongoliaChina14010
    82Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjingJiangsuChina210000
    83The Second Affiliated Hospital of Nanjing Medical UniversityNanjingJiangsuChina210011
    84The Second Affiliated Hospital of Nanchang UniversityNanchangJiangxiChina330006
    85Jiangxi Pingxiang People's HospitalPingxiangJiangxiChina337055
    86Jilin Province People's HospitalChangchunJilinChina130021
    87China-Japan Union Hospital, CJUH.ChangchunJilinChina130033
    88The first affiliated hospital of dalian medical universityDalian ShiLiaoningChina116000
    89The People's Hospital of Liaoning ProvinceShenyangLiaoningChina110000
    90Jinan Central HospitalJinanShandongChina250013
    91Zhongshan Hospital,Fudan UniversityShanghaiShanghaiChina200032
    92Huashan Hospital Affiliated Fudan UniversityShanghaiShanghaiChina200040
    93West China Hospital Sichuan UniversityCheng DuSichuanChina610041
    94G.B. Pant Institute of Postgraduate Medical Education & ResearchNew DelhiDelhiIndia110002
    95Batra Hospital and Medical Research CentreNew DelhiDelhiIndia110062
    96CIMS Hospital - Care Institute of Medical SciencesAhmedabadGujaratIndia380060
    97Medanta The MedicityGurugramHaryanaIndia122018
    98Narayana Institute of Cardiac SciencesBangaloreKarnatakaIndia560099
    99King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical CollegeMumbaiMaharashtraIndia400012
    100Government Medical College And Hospital - NagpurNagpurMaharashtraIndia440009
    101Central India Cardiology and Research InstituteNagpurMaharashtraIndia440015
    102AIG HospitalsHyderabadTelanganaIndia500032
    103Barzilai Medical CenterAshkelonHaDaromIsrael7830604
    104Meir Medical CenterKfar SabaHaMerkazIsrael4428164
    105Rabin Medical CenterPetah-TikvaHaMerkazIsrael4941492
    106Sheba Medical CenterRamat GanHaMerkazIsrael5262100
    107Kaplan Medical CenterRehovotHaMerkazIsrael7610001
    108Hillel Yaffe Medical CenterHaderaHaTsafonIsrael3810101
    109Rambam Health Care CampusHaifaHaTsafonIsrael3109601
    110Galilee Medical CenterNahariyaHaTsafonIsrael2210001
    111Shaare Zedek Medical CenterJerusalemYerushalayimIsrael9013102
    112Hadassah Medical CenterJerusalemYerushalayimIsrael9112001
    113CIMAB SA de CVTorreónCoahuilaMexico27000
    114Virgen Cardiovascular Research SCGuadalajaraJaliscoMexico44670
    115Cardiolink Clin TrialsMonterreyNuevo LeónMexico64060
    116Hospital Universitario "Dr. Jose Eleuterio Gonzalez"MonterreyNuevo LeónMexico66460
    117Hospital Cardiologica AguescalientesAguascalientesMexico20230
    118Centro de Estudios Clínicos de Querétaro (CECLIQ)QuerétaroMexico76000
    119Clinical Research Center - Universidad Central del Caribe (CRC - UCC)BayamonPuerto Rico00956
    120Research and Cardiovascular Corp.PoncePuerto Rico00717
    121Ivanovo Regional Healthcare Institution Cardiology DispensaryIvanovoIvanovskayRussian Federation153012
    122Russian Cardiology Research and Production ComplexMoscowMoskvaRussian Federation121552
    123Russian Medical Academy of Postgraduate EducationMoscowMoskvaRussian Federation251284
    124Ryazan Regional Clinical Cardiological DispensaryRyazanRyazanskaya Oblast'Russian Federation390026
    125Astarta ClinicSaint-PetersburgSankt-PeterburgRussian Federation199226
    126Izhevsk City Clinical Hospital Number 9IzhevskUdmurtskaya RespublikaRussian Federation426063
    127Mackay Memorial Hospital-HsinchuHsinchu CityHsinchuTaiwan300
    128Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiungTaiwan807
    129Chung Shan Medical University HospitalTaichungTaiwan402
    130Taipei Veterans General HospitalTaipei R. O. C.Taiwan112
    131National Taiwan University HospitalTaipeiTaiwan10002
    132Taipei Medical University HospitalTaipeiTaiwan110
    133Chang Gung Medical Foundation-Linkou BranchTaoyuanTaiwan333

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04847557
    Other Study ID Numbers:
    • 17757
    • I8F-MC-GPID
    First Posted:
    Apr 19, 2021
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 18, 2021